This invention relates to devices for collecting, testing and transporting liquid biological specimens of bodily fluids, such as urine, and methods for testing such a specimen. More particularly, the invention relates to disposable containers for collecting liquid specimens that are capped following collection, the design of which facilitates accurately testing a portion of the collected sample at the container, without removing the cap, in a manner so that the remainder of the sample remains unadulterated and can be shipped to a laboratory or the like for controlled testing to confirm the initial test results.
Testing of bodily fluid specimens, such as urine, has become well known in today""s society, but such testing has frequently exposed the tester to contact with such bodily fluid, either necessarily or inadvertently, while carrying out such a test procedure. Moreover, there is often a need, as in hospital emergency rooms or the like, to carry out such tasks quickly, and such may have a further propensity for exposure of the tester.
A number of approaches have been made as potential solutions for this problem. For example, U.S. Pat. No. 5,976,895 shows a drug abuse test kit wherein a cup for holding the urine specimen has a threaded upper edge and is fitted with an inner closure insert once the sample is in place. The insert has a diametrical slit through which a multiple drug test card, carrying a plurality of immunoassay test strips, can be slid before a screw cap or closure is threaded into place to close the container. The visual end points of the test strips are viewed through the transparent container wall; however, the entire sample remains in contact with the test card raising the possibility that some contamination from the test card could occur during transporting to an analytical laboratory whenever confirmatory testing would be performed under highly controlled conditions.
U.S. Pat. No. 5,119,830 shows a device where an analytical specimen cup is fitted with a specialized cap that can be secured to the container by the donor so that the person monitoring the testing need not be at all exposed, as they will be handed a closed container. The specialized cap is then manipulated to break a frangible barrier that opens a compartment in the cap to communicate with the cup containing liquid specimen; thereafter, inversion of the cup fills the lid compartment and contacts a test strip with the specimen, causing the immunoassay to be carried out, with color change being viewed through the transparent upper flexible sheet carried by the lid.
A number of other variations of this type of device have been designed where a specialized cap is provided with assay test strips and with a valve of some type that can be manipulated while the cup remains closed and thus cannot contaminate the person carrying out the test. Devices of this type are shown in U.S. Pat. Nos. 4,690,801; 5,429,804; 5,501,837; 5,591,401; and 6,074,606. Test devices of the same theme have been developed to fit with a rectangular container where the lid is of two-part construction, interconnected by a living hinge; chemical test strips are provided in a test space located in a compartment on the underside of the inner cover into which the specimen can pass once a frangible closure is broken, as shown for example in U.S. Pat. No. 5,640,969 and 5,882,600. In another variation on this theme, U.S. Pat. No. 6,168,758 shows a specialized cap which is threaded onto a cylindrical specimen cup and includes a plurality of chromatography strips which will visually display the assay result. Once the cap is secure, the container is inverted causing a reservoir underside of the cap to fill and collect a predetermined volume of the liquid specimen with the specimen being transmitted via wicking. During the filling of the reservoir, the intention is that a valve member will automatically swell, by absorption of liquid, and eventually close the passageway so that there will no longer be communication between the filled reservoir and the remainder of the specimen sample in the container itself. A further variation on this theme is shown in U.S. Pat. No. 5,403,551 where, instead of locating the assay test elements on the underside of the cap, they are located in a separate chamber constructed in the side wall of the specimen container itself, having an entrance opening near the very top thereof. Once the donor has contributed the specimen, a screw-on cap is applied, and through rotative positioning of the cap, a valve leading to the side wall chamber can be opened or closed. By opening the valve and inverting the cup, the reservoir in the side chamber can be filled with a sample of the specimen while the cap remains in an essentially closed condition. The results of the testing can be observed through the transparent side wall of the chamber or the like. A device shown in U.S. Pat. No. 4,473,530 is generally similar.
More recently, a primary concern with testing of urine samples or the like is to assure that, when an initial test is run, no back contamination can potentially occur between the materials used in such initial test and the remainder of the untested specimen in the cup or container. U.S. Pat. No. 4,109,530 shows a liquid specimen transfer container that is designed to provide two interconnected storage chambers in order to avoid cross-contamination therebetween. U.S. Pat. No. 5,897,840 applies this concept to a multi-chambered urine specimen container wherein the interconnection of a specialized cap with a depending tubular wall segregates two concentric chambers. The central chamber is provided with a septum through which a hypodermic needle can be inserted to extract a sample, and the outer chamber is emptied via an integral upstanding spout formed near the periphery of the cap, the tip of which can be cut off by a pair of scissors.
U.S. Pat. No. 4,927,605 shows a somewhat more complicated specimen collection container wherein the lid is placed atop the cup holding the urine sample. One or more evacuated tubes are opened through the use of hollow needles and allowed to fill with a portion of the urine sample, which tubes can then be removed from the chamber by peeling off a flexible cover to expose a removal opening. In several alternative embodiments, an isolatable chamber is provided in the lower portion of the specimen-collecting cup which has an opening that is automatically closed by the application of the cap or lid, allowing the segregated chamber to be accessed through a side sample port that will allow withdrawal of the sample from the subchamber to an appropriate testing vessel while preserving the major portion of the collected specimen without potential contamination as a result of the withdrawal of the sample from the segregated subchamber.
Although many of the foregoing devices, if handled precisely as intended, could provide for adequately testing a sample of a liquid specimen without exposing the tester to the specimen and in a manner so that there would be very little potential for contamination or adulteration of the remaining sample as a result of contact with, and particularly prolonged contact with, the assay materials themselves; however, the foregoing presupposes complete training of all testing personnel to precisely carry out the assay and presupposes the careful attention of each person to such details. In a imperfect world, solutions to this problem have continued to be sought, particularly ones that would simplify the procedure and the construction of such devices. Overall, better solutions are sought which will eliminate any possibility of tampering with the assay by the donor, i.e. by the donor never having possession of the testing mechanism, and in which a sealed container is simply supplied to the monitor/tester who can immediately and simply carry out an initial accurate test in a manner that positively avoids cross contamination with the remainder of the specimen.
The invention provides a device for collecting, testing and transporting a liquid sample of bodily fluid, e.g. a urine specimen or the like, which is simple in construction and economical to manufacture, which avoids potential adulteration of the main portion of the specimen by possible intercommunication with the test materials and which segregates a liquid sample of defined volume from the remainder of the liquid specimen in a manner in which it can be initially tested at the container without danger of exposure to the tester. The device utilizes a container or cup designed to provide a main chamber for storing the bulk of the liquid specimen, which has a subchamber formed in its bottom wall. It is used in combination with a lid for closing the upper opening into the cup, which lid is constructed with a depending hollow tube section that includes an initially closed aperture at its terminus. The device is used in combination with a test element or cartridge that is proportioned for insertion of its lower end through this aperture into this subchamber. The depending hollow tube section has a lower end which seals with an interior wall of the subchamber and thereby isolates a defined volume of liquid within the subchamber from the remainder of the liquid specimen in the container. The test cartridge has a casing which is assembled from two of the same parts that snap together as mirror images. Its bottom end opens the closed aperture at the terminus of the hollow tube section and slides through it while mating with the bottom section of the interior of the hollow tube to allow controlled leakage therepast. A wicking arrangement then transfers the defined volume of liquid from the subchamber to an assay strip which provides a response that is detectable exterior of the container, as through a window in a region of the test cartridge casing that extends above the lid. This arrangement allows initial testing to readily be carried out at the container by simply inserting the test cartridge so that it splits and passes through the frangible seal, while eliminating the possibility of cross contamination of the remainder of the specimen.